Regular Home Use of Dual-light Photodynamic Therapy on Oral Health in Adolescents Undergoing Fixed Orthodontic Treatment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-05

Study Completion Date

2025-03-05

Brief Summary

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This study is designed to determine the efficacy of the Lumoral method on oral health in adolescents undergoing fixed orthodontic treatment. Improved supragingival plaque control can help to also sustain the subgingival plaque management in the long term. In addition, the device might have a photobiomodulation effect on periodontal tissues.

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Detailed Description

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Orthodontic treatment is one of the most common dental treatments in children and adolescents. The use of fixed orthodontic appliances makes it difficult for the patients to keep their oral hygiene to an optimum level of cleanliness. Poor oral hygiene attracts significant plaque accumulation around the fixed orthodontic treatment appliances, and subsequent white spot lesions can occur rapidly, usually on the cervical and middle third of the buccal surfaces of bracketed teeth. Patients with the fixed orthodontic treatment appliances have an increased risk of caries and gingivitis.

The Lumoral is a CE-marked medical device developed to provide a potent, targeted antibacterial action on dental plaque in a home environment. The device mechanism of action is antibacterial photodynamic therapy (aPDT). The device is used by swishing a mouth rinse, which has a strong adherence to dental plaque. The plaque-adhered photoactive mouth rinse can be activated by a simple to use light applicator. Preliminary results have shown a promising anti-inflammatory response in addition to plaque reduction.

Forty (40) subjects undergoing fixed orthodontic treatment are randomized to the Lumoral treatment group or the control group. All subjects shall receive polishing and oral hygiene instruction. All patients shall be assessed for the clinical measurements including visible plaque index (VPI), bleeding on probing (BOP), and orthodontic plaque index (OPI) at baseline and at 4 weeks and 12 weeks after baseline. In addition, microbiological analyses shall be performed at baseline and at 12 weeks after baseline.

Conditions

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Orthodontic Appliance Complication Plaque, Dental Gingival Inflammation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants in two groups (Study group and Control group) shall receive instructions for standard oral hygiene. The same assessments are done for participants in both groups, and within the same time periods. The Study group will also be using the Lumoral Treatment device.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

The participants, care providers, and investigators shall be masked before the first measurements. The randomization will be conducted after the first measurements.

Study Groups

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Lumoral Treatment (Study group)

Subjects will receive detailed instructions for the use of Lumoral treatment -device. Subjects will be instructed to use the Lumoral treatment -device and follow the protocol once a day for two months and to keep a diary.

Subjects will receive the latest standard oral hygiene instructions according to the Swedish dental association's guidelines.

Group Type EXPERIMENTAL

Lumoral Treatment

Intervention Type DEVICE

Subjects will receive detailed instructions for the use of Lumoral treatment -device. Subjects will be instructed to use the Lumoral treatment -device and follow the protocol once a day for two months and to keep a diary.

Standard oral health instructions

Intervention Type OTHER

Subjects will receive the latest standard oral hygiene instructions according to the Swedish dental association's guidelines.

Standard of care (Control group)

Subjects will receive the latest standard oral hygiene instructions according to the Swedish dental association's guidelines.

Group Type OTHER

Standard oral health instructions

Intervention Type OTHER

Subjects will receive the latest standard oral hygiene instructions according to the Swedish dental association's guidelines.

Interventions

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Lumoral Treatment

Subjects will receive detailed instructions for the use of Lumoral treatment -device. Subjects will be instructed to use the Lumoral treatment -device and follow the protocol once a day for two months and to keep a diary.

Intervention Type DEVICE

Standard oral health instructions

Subjects will receive the latest standard oral hygiene instructions according to the Swedish dental association's guidelines.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* age of 15-18 years old
* starting fixed orthodontic treatment
* good oral hygiene according to the dentist's assessment
* absence of periodontal disease and lack of oral lesion
* signed a written consent form, including information to caregivers.

Exclusion Criteria

* any chronic diseases
* medications that could influence the study (according to the dentists' assessment)
* active caries or a supposed high risk of caries
* gingivitis (bleeding on probing \>10%)
* use of antiseptic mouthwashes
* smoking
* use of antibiotics or anti-inflammatory therapy within 3 months before entering the study or during the study
* unable to cooperate with the protocol.
* pregnancy or lactation

Minimum Eligible Age

15 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No